Chinese Journal of Tissue Engineering Research ›› 2026, Vol. 30 ›› Issue (34): 9056-9066.doi: 10.12307/2026.868
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Wu Ruiqi1, 2, Dong Panfeng1, Zhang Hongrui1, 2, Lyu Yongbin1, 2, Peng Qinglin1, Zhuo Yinghong1, Chen Yueping1
Received:2025-11-19
Revised:2026-01-23
Online:2026-12-08
Published:2026-04-15
Contact:
Dong Panfeng, MS, Associate chief physician, Associate professor, Master’s supervisor, Affiliated Ruikang Hospital of Guangxi University of Chinese Medicine, Nanning 530000, Guangxi Zhuang Autonomous Region, China
About author:Wu Ruiqi, PhD candidate, Affiliated Ruikang Hospital of Guangxi University of Chinese Medicine, Nanning 530000, Guangxi Zhuang Autonomous Region, China; Guangxi University of Chinese Medicine, Nanning 530299, Guangxi Zhuang Autonomous Region, China
Corresponding author: Chen Yueping, PhD, Chief physician, Doctoral supervisor, Affiliated Ruikang Hospital of Guangxi University of Chinese Medicine, Nanning 530000, Guangxi Zhuang Autonomous Region, China
Supported by:CLC Number:
Wu Ruiqi, Dong Panfeng, Zhang Hongrui, Lyu Yongbin, Peng Qinglin, Zhuo Yinghong, Chen Yueping . Different physical factor therapies for knee osteoarthritis: a network meta-analysis of efficacy and safety[J]. Chinese Journal of Tissue Engineering Research, 2026, 30(34): 9056-9066.
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2.1 文献检索结果 初步搜索获得1 832篇文献,通过EndNote X9自动结合手动剔除重复文献后剩余1 123篇,阅读标题和摘要后排除一些不相关且明显不符合纳入要求的文章,如动物细胞实验、手术相关研究、病例报告和综述等,下载了175篇文献以供进一步筛选。通过阅读全文,排除不符合纳入标准的文献,最终纳入65个随机对照试验。文献筛选流程见图3。 2.2 纳入文献的基本特征 共纳入3 418例患者,均符合膝骨关节炎的临床诊断,其中治疗组1 726例、对照组1 692例,入选患者年龄40-75岁,其中55-70岁最常见。使用常规康复治疗作为对照组,包括常规的关节活动度训练、肌力训练、日常功能训练及一般护理指导等,试验组为常规康复治疗联合物理因子治疗,涉及超声波、脉冲电磁场、低能量激光、体外冲击波、经皮电刺激、全身振动和肌内效贴7种物理因子治疗,治疗持续时间为4-12周。结局指标方面,报道治疗总有效率的共有33项研究、膝关节目测类比评分的共有57项研究、WOMAC总评分的共有35项研究、WOMAC关节僵硬评分的共有29项研究,SF-36量表的24项研究、Lysholm膝关节评分的共有39项研究。纳入文献的基本特征,见表1。 2.3 纳入文献的质量评价 纳入65篇文献均为随机对照试验[21-85]。随机顺序产生方面,29项为随机数字表法[22-23,28-30,32,35,39-41,45,48,57-59,63,65-67,69,71,74-77,79-80,83-84],2项采用抽签随机法[51,54],1项采用分层区组随机[69],以上研究均判为“低风险”,1项根据治疗方案的不同进行分组[36],2项按照患者采用就诊先后顺序[24,70],均判为“高风险”,其余研究未报告具体随机方法判为“风险未知”。分配隐藏方面,7项研究采用信封法进行分配隐藏[26,59,29,67,69-70,83],判为“低风险”,其余研究均未提及分配隐藏方案,评为“风险未知”。盲法方面,13项研究采用双盲[27,29,32,39,42,52,59,65,67,69,72-73,83],均判为“低风险”, 其余研究均未提及盲法判为“风险未知”。纳入研究数据完整,结局评价可靠,评为“低风险”。在选择性报告方面,均未在中国临床试验注册中心上搜索到研究计划书均评为“风险未知”。在其他来源偏倚风险方面,所有研究对资助来源等方面未报告均评为“风险未知”。采用RevMan 5.3软件绘制纳入研究的偏倚风险图,见图4。 2.4 治疗总有效率分析结果 2.4.1 证据网络 33项随机对照试验报道了治疗总有效率[23,26,31,39-40,47-49,51-56,58-70,73-75,80-82],共涉及8种干预措施:超声波+常规康复、脉冲电磁场+常规康复、低能量激光+常规康复、体外冲击波+常规康复、经皮电刺激+常规康复、全身振动+常规康复、肌内效贴+常规康复和单纯常规康复治疗,总样本量2 689例。网络图中,各圆点分别表示不同的干预措施,圆点大小代表此干预措施的样本量,圆点之间连线粗细代表各干预措施的研究数量,直线表示2种干预措施间存在的直接或间接比较,不同干预措施间均存在直接或间接比较的证据,具备进行网状Meta分析的基本条件。治疗有效率的证据网络总体以常规康复治疗为中心,干预措施间无闭合环产生,无需进行不一致性检验,见图5A。 2.4.2 网状Meta分析与SUCRA排序 对8种干预措施进行两两比较,共产生28项两两比较。网状Meta分析显示,肌内效贴+常规康复(OR=1.17,95%CI[1.07,1.29])、经皮电刺激+常规康复(OR=1.18,95%CI[1.12,1.26])、体外冲击波+常规康复(OR=1.17,95%CI[1.12,1.22])、脉冲电磁场+常规康复(OR=1.28,95%CI [1.03,1.57])、超声波+常规康复治疗(OR=1.24,95%CI[1.11,1.39])治疗在提高治疗总有效率均优于单纯常规康复治疗(P < 0.05),其余干预措施间治疗总有效率相比较差异无显著性意义 (P > 0.05),见图6A。 在报告治疗总有效率的研究中,治疗总有效率的SUCRA值由高到低排序为:脉冲电磁场+常规康复(77.5%) >超声波+常规康复(76.8%) >经皮电刺激+常规康复(56.5%) >肌内效贴+常规康复(51.4%) >低能量激光+常规康复(50.0%) >体外冲击波+常规康复(47.4%) >全身振动+常规康复(38.7%) >常规康复(2.6%),见图7A。"
2.5 膝关节目测类比评分分析结果 2.5.1 证据网络 57项随机对照试验报道了膝关节目测类比评分[22-28,30-33,35,37-45,47-60,62-80,83-85],共涉及8种干预措施,总样本量4 044例,证据网络总体以常规康复治疗为中心,干预措施间无闭合环产生,故无需进行不一致性检验,见图5B。 2.5.2 网状Meta分析与SUCRA排序 对8种干预措施进行两两比较,共产生28项两两比较。网状Meta分析显示,经皮电刺激+常规康复(SMD=-1.55,95%CI[-2.38,-0.73])、体外冲击波+常规康复(SMD=-1.27,95%CI[-1.88,-0.66])、超声波+常规康复(SMD=-1.15,95%CI [-1.89,-0.41])治疗在改善膝关节目测类比评分方面优于常规康复治疗(P < 0.05),其余干预措施间相膝关节目测类比评分比较差异无显著性意义(P > 0.05),见图6B。 在报告膝关节目测类比评分的研究中,膝关节目测类比评分的SUCRA值概率排序为:经皮电刺激+常规康复(85.6%) >体外冲击波+常规康复(72.9%) >超声波+常规康复(65.8%) >肌内效贴+常规康复(57.1%) >脉冲电磁场+常规康复(53.0%) >低能量激光+常规康复(34.1%) >全身振动+常规康复(25.4%) >常规康复(6.1%),见图7B。 2.6 WOMAC总评分分析结果 2.6.1 证据网络 35项随机对照试验报道了WOMAC总评分[21-22,24,28-29,32-35,38,40,46,48-50,52-54,57-58,60,63,65,67,69,72,74-75,77-80,83-85],共涉及9种干预措施,总样本量2 379例,证据网络总体以常规康复治疗为中心,干预措施间产生闭合环,见图5C。为了确保分析结果的稳健性,需运用节点分裂法进行局部的一致性检验,检验结果显示P > 0.05,是说明研究间具有一致性,故在一致性模型下进行网状Meta分析。对闭环进行一致性检验,结果显示闭环IF=1.98、95%CI[0.73,3.42],提示一致性良好。 2.6.2 网状Meta分析与SUCRA排序 对9种干预措施进行两两比较,共产生36项两两比较。网状Meta分析显示,与常规康复治疗相比,肌内效贴+常规康复(SMD=-0.70,95%CI[-1.25,-0.15])、经皮电刺激+常规康复(SMD=-1.03,95%CI[-1.44,-0.62])、体外冲击波+常规康复(SMD=-1.06,95%CI[-1.99,-0.12])、低能量激光+常规康复(SMD=-1.18,95%CI[-1.83,-0.52])、脉冲电磁场+常规康复(SMD=-1.24,95%CI[-1.81,-0.67])治疗在减少WOMAC总评分方面的效果更佳(P < 0.05),其余干预措施间WOMAC总评分相比较差异无显著性意义(P > 0.05),见图6C。 在报告WOMAC总评分的研究中,WOMAC总评分的SUCRA值由高到低排序为:超声波+常规康复(77.6%) >脉冲电磁场+常规康复(72.9%) >超声波+经皮电刺激+常规康复治疗(66.0%) >低能量激光+常规康复(63.8%) >体外冲击波+常规康复(63.5%) >全身振动+常规康复(40.7%) >肌内效贴+常规康复(31.3%) >经皮电刺激+常规康复(29.7%) >常规康复(4.6%),见图7C。 2.7 WOMAC关节僵硬评分分析结果 2.7.1 证据网络 27项随机对照试验报道了WOMAC关节僵硬评分[21-22,24,28-31,33-34,37-38,41-46,49-50,52,55,57,72,76,79,82-83],共涉及9种干预措施,总样本量2 000例,证据网络总体以常规康复治疗为中心,干预措施间无闭合环产生,故无需进行不一致性检验,见图5D。 2.7.2 网状Meta分析与SUCRA排序 对9种干预措施进行两两比较,共产生36项两两比较。网状Meta分析显示,与常规康复治疗相比,超声波+经皮电刺激+常规康复(SMD=-1.19,95%CI[-2.10,-0.28])、经皮电刺激+常规康复(SMD=-1.52,95%CI[-2.18,-0.87])、体外冲击波+常规康复(SMD=-0.73,95%CI[-1.12,-0.34])、低能量激光+常规康复(SMD=-0.51,95%CI[-0.92,-0.11])、超声波+常规康复(SMD=-1.26,95%CI[-1.63,-0.89])在减少WOMAC关节僵硬评分方面的效果更佳。此外,经皮电刺激+常规康复治疗在减少WOMAC关节僵硬评分方面优于全身振动+常规康复(SMD=-1.10,95%CI[-1.99,-0.22]),超声波+常规康复治疗在减少WOMAC关节僵硬评分方面优于全身振动+常规康复(SMD=-0.83,95%CI[-1.54,-0.13])、低能量激光+常规康复(SMD=-0.75,95%CI[-1.29,-0.20])、脉冲电磁场+常规康复(SMD=-0.83,95%CI[-1.42,-0.24])治疗,差异有显著性意义(P < 0.05),其余干预措施间WOMAC关节僵硬评分比较差异无显著性意义(P > 0.05),见图6D。 在报告WOMAC关节僵硬评分的研究中,WOMAC关节僵硬评分的SUCRA值由高到低排序为:经皮电刺激+常规康复(92.8%) >超声波+常规康复(83.9%) >超声波+经皮电刺激+常规康复(75.9%) >体外冲击波治疗+常规康复治疗(53.1%) >肌内效贴+常规康复(44.0%) >低能量激光+常规康复(37.0%) >全身振动+常规康复(30.9%) >脉冲电磁场+常规康复(30.1%) >常规康复(3.0%),见图7D。 2.8 SF-36量表分析结果 2.8.1 证据网络 25项随机对照试验报道了SF-36量表[25-26,28-30,32-33,36,39,41,46,51,56,60,65-66,68,71,76-77,79,81,83-85],共涉及8种干预措施,总样本量1 727例,证据网络总体以常规康复治疗为中心,干预措施间无闭合环产生,故无需进行不一致性检验,见图5E。 2.8.2 网状Meta分析与SUCRA排序 对8种干预措施进行两两比较,共产生28项两两比较。网状Meta分析显示,肌内效贴+常规康复(SMD=0.63,95%CI[0.05,1.21])、全身振动+常规康复(SMD=0.93,95%CI[0.22,1.64])、体外冲击波+常规康复(SMD=0.97,95%CI[0.37,1.56])、脉冲电磁场+常规康复(SMD= 0.98,95%CI[0.35,1.60])、超声波+常规康复(SMD=0.93,95%CI[0.51,1.35])治疗在改善SF-36量表方面优于常规康复治疗(P < 0.05),其余干预措施间SF-36量表相比较差异无显著性意义(P > 0.05),见图6E。 在报告SF-36量表的研究中,SF-36量表的SUCRA值由高到低排序为:脉冲电磁场+常规康复(72.8%) >体外冲击波+常规康复(72.2%) >超声波治疗+常规康复(70.8%) >全身振动+常规康复(68.4%) >肌内效贴+常规康复(45.4%) >经皮电刺激+常规康复(35.9%) >低能量激光+常规康复(29.8%) >常规康复(4.7%),见图7E。 2.9 Lysholm膝关节评分分析结果 2.9.1 证据网络 38项随机对照试验报道了Lysholm膝关节评分[21,23-24,26,30,33-34,38-46,48-52,55,57-60,62-63,66,69-71,73,76,78-79,81,84],共涉及9种干预措施,总样本量2 783例,证据网络总体以常规康复治疗为中心,干预措施间无闭合环产生,故无需进行不一致性检验,见图5F。2.9.2 网状Meta分析与SUCRA排序 对9种干预措施进行两两比较,共产生36项两两比较。网状Meta分析显示,超声波+经皮电刺激+常规康复(SMD=1.80,95%CI[0.36,3.23])、经皮电刺激+常规康复(SMD=0.88,95%CI[0.29,1.46])、体外冲击波+常规康复(SMD=1.25,95%CI[0.86,1.65])、低能量激光+常规康复(SMD=0.68,95%CI[0.16,1.20])、超声波+常规康复(SMD=1.58,95%CI[0.91,2.25])治疗在改善Lysholm膝关节评分方面优于常规康复治疗(P < 0.05);此外,体外冲击波+常规康复治疗在改善Lysholm膝关节评分方面优于脉冲电磁场+常规康复治疗(SMD=0.87,95%CI[0.16,1.58]),超声波+常规康复治疗在改善Lysholm膝关节评分方面优于脉冲电磁场+常规康复(SMD=1.20,95%CI[0.30,2.09])、低能量激光+常规康复治疗(SMD=0.90,95%CI[0.05,1.75]),差异有显著性意义(P < 0.05),其余干预措施间"
Lysholm膝关节评分比较差异无显著性意义(P > 0.05),见图6F。 在报告Lysholm膝关节评分的研究中,Lysholm膝关节评分的SUCRA值由高到低排序为:超声波+常规康复(86.6%) >超声波+经皮电刺激+常规康复(86.5%) >体外冲击波+常规康复(74.1%) >经皮电刺激+常规康复(51.5%) >肌内效贴+常规康复(48.0%) >全身振动+常规康复(39.7%) >低能量激光+常规康复(38.9%) >脉冲电磁场+常规康复(22.3%) >常规康复(4.5%),见图7F。 2.10 不良反应发生率 46项随机对照试验报道了不良反应发生率[21,23-25,27-30,32,34-36,39,41-43,45-47,49-50,53,55-57,59-61,63-67,70-73,75,77-82,84-85],其中,32篇报告治疗期间均未发生与干预措施等相关的不良反应,14篇对不良反应发生情况进行了描述,共涉及8种干预措施,共有65例患者出现不良反应,主要包括皮肤刺激、过敏反应、肌肉或关节的酸痛感和治疗部位稍肿胀等表现,由于每个研究间不良反应不同,因此只作描述性统计,见表2。 2.11 文献发表偏倚 此次研究对各结局指标进行发表偏倚分析,绘制“比较-矫正”漏斗图,进行偏倚分析,漏斗图中的圆点表示不同干预措施之间的一对一比较,点的颜色代表不同的干预措施或对照组类别,每种颜色点的数量代表报告比较的研究数量。如果不存在小样本量或发表偏差的影响,漏斗图中的点对称且均匀分布在垂直线的两侧(X=0)。检验结果显示,治疗总有效率、WOMAC总评分、WOMAC关节僵硬评分、SF-36量表和Lysholm膝关节评分结局指标的纳入研究总体对称分布于倒漏斗图的中上部,围绕中线左右两侧,提示发表偏倚的可能性较小;膝关节目测类比评分结局指标的漏斗图左右对称性欠佳,并且部分圆点散落在95%CI区域外,提示纳入文献可能存在一定的发表偏倚或是小样本效应,见图8。 进一步进行对所有结局指标进行敏感性分析Egger检验,结果显示治疗总有效率的P=0.532、膝关节目测类比评分的 P=0.780、WOMAC总评分的P=0.322、WOMAC关节僵硬评分的P=0.725、SF-36量表的P=0.617、Lysholm膝关节评分的P=0.403,提示所纳入的研究不存在小样本研究效应且具有一定的稳健性。"
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